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BPFK NPCB : UNTUK PERMOHONAN BAGI LESEN – LESEN PENGILANG, MENGIMPORT DAN PEMBORONG KELUARAN – KELUARAN BERDAFTAR

SENARAI KANDUNGAN

PENDAHULUAN

Garis panduan ini disediakan dengan tujuan unntuk memberi panduan dan sebagai rujukan kepada semua pelanggan Pusat Komplians Dan Pelesenan dalam memahami proses aliran kerja pemprosesan permohonan lesen. Dengan adanya Garis Panduan Permohonan Lesen ini, diharap pelanggan – pelanggan yang berurusan dengan Pusat ini akan mengikuti tatacara yang telah ditetapkan demi memastikan kelancaran pengeluaran lesen yang dipohon.

LATAR BELAKANG OBJEKTIF

FUNGSI PUSAT KOMPLIANS DAN PELESENAN

PIAGAM PELANGGAN

Setiap permohonan lesen yang diterima akan diluluskan dalam tempoh 30 hari dari tarikh lengkap

KOD BORANG PERMOHONAN, JENIS – JENIS LESEN DAN KADAR BAYARAN

KOD BORANG PERMOHONAN	JENIS LESEN	KADAR BAYARAN BPFK – 422/2 LB	LESEN PEMBORONG	RM 500 BPFK – 424/2 LI	LESEN MENGIMPORT	RM 500 BPFK – 426/2 LK	LESEN PENGILANG	RM 1000

Note : Lesen yang dikeluarkan adalah untuk semua kategori produk (A,X,T) kecuali kategori kosmetik(K)

KEPERLUAN – KEPERLUAN DI BAWAH PERATURAN – PERATURAN KAWALAN DADAH DAN KOSMETIK, 1984 _____________________________________________________________________________

	Peraturan 7

1.	Menyatakan “tiada seorang pun boleh mengilang, menjual, membekal atau                mengimport apa – apa keluaran melainkan jika :

(a)	keluaran itu ialah suatu keluaran berdaftar ; dan (b)	mempunyai lesen yang sesuai, yang dikehendaki dan dikeluarkan di bawah Peraturan – Peraturan ini.

2. 	Memberi pengecualian kepada seorang peruncit berdasarkan keperluan subperaturan  (1)(b).

3. Memberi pengecualian dari kehendak pengimportan di bawah subperaturan (1)sekiranya keluaran tersebut dibawa masuk dari suatu tempat di luar persekutuan sebagai sebahagian dari lugej peribadi ( dengan syarat keluaran itu adalah untuk kegunaan sendiri atau keluarganya dan tidak melebihi kuantiti penggunaan untuk satu bulan ) atau di bawa oleh mana – mana pegawai kerajaan yang menjalankan kewajipannya atau di bawa dalam transit, tertakluk kepada syarat – syarat tertentu.

	Peraturan 12 1.	Memberi kuasa kepada Pihak Berkuasa Kawalan Dadah (PBKD) mengeluarkan lesen – lesen pengilang, pemborong dan mengimport, tertakluk kepada apa – apa syarat yang mungkin dikenakan. Aktiviti pengilangan, jualan atau bekalan secara borong dan pengimportan hanya dibenarkan untuk premis yang dinyatakan dalam lesen sahaja.

6.	Menyatakan setiap lesen hendaklah menjadi peribadi kepada pemegang lesen yang telah dinamakan dan tidak boleh dipindahkan kepada seorang yang lain.

	Peraturan 14

Memberi kuasa kepada PBKD untuk menolak mana – mana permohonan lesen jika ia fikirkan patut dan tanpa memberi apa –apa sebab terdahulu.

	Peraturan 17 Memberi kuasa kepada PBKD pada bila – bila masa dan tanpa memberi apa – apa sebab, menggantung atau membatalkan pendaftaran apa – apa keluaran atau menarik balik apa – apa lesen yang dikeluarkan dan boleh meminda syarat – syarat lesen atau pendaftaran itu.

CARA – CARA PERMOHONAN

Permohonan lesen pengilang, lesen mengimport dan lesen pemborong boleh dibuat secara :

I.	Manual

	Pemohon boleh melayari laman web Biro Pengawalan Farmaseutikal Kebangsaan (www.bpfk.gov.my) dan memuat turun borang permohonan lesen yang dikehendaki. Borang yang lengkap berserta dengan lampiran yang dikehendaki, hendaklah di hantar ke ;

Pusat Komplians & Pelesenan Biro Pengawalan Farmaseutikal Kebangsaan Kementerian Kesihatan Malaysia P.O.B 319 Jalan Universiti 46730 Petaling Jaya, Selangor II. Online

	Pemohon juga boleh membuat permohonan secara online di (www.bpfk.gov.my)    melalui sistem Quest.

CARA – CARA PEMBAYARAN

I.	Manual

	Pembayaran untuk permohonan secara “manual” boleh dibuat sama ada menggunakan Bank Draft / Money Order. 	Pemohon perlu menghantar Bank Draft/Money Order bersama dengan borang permohonan lesen yang lengkap ke Pusat Komplians & Pelesenan. II. Online 	Untuk permohonan secara “online” pemohon perlu mencetak “payment voucher” dari laman web selepas mengisi permohonan online. 	Payment Voucher bersama Bank Draft/Money Order perlu di hantar ke Pusat Pentadbiran, BPFK.

SENARAI SEMAKAN UNTUK PERMOHONAN LESEN PENGILANG, MENGIMPORT ATAU PEMBORONG

	Borang permohonan yang telah disikan sepenuhnya. 	Draf Bank/Kiriman Wang atau Wang Pos untuk bayaran fee pemprosesan ke Biro Pengawalan Farmaseutikal Kebangsaan. (Nota;Cek Persendirian/Cek Syarikat tidak diterima) 	Carta Organisasi lengkap dengan nama kakitangan 	Prosedur lengkap panggil balik (2 orang bertanggungjawab,nama,jawatan,alamat,nombor telefon untuk dihubungi) 	Salinan Sijil Lesen Perniagaan (Majlis Kerajaan Tempatan) 	Salinan Sijil Pendaftaran Syarikat 	(a)	Bagi permohonan Lesen Pengilang : -	Lokasi dan Pelan Kilang -	Senarai Kelengkapan (pengeluaran mutu) (c)	Bagi permohonan Lesen Mengimport dan Lesen Pemborong -	Lokasi dan pelan premis/stor -	Senarai kelengkapan penstoran -	Butir – butir keluaran lain (bukan ubat) yang akan disimpan di premis yang sama. 	Jika pemohon adalah seorang Ahli Farmasi -	Salinan Sijil Pendaftaran Ahli Farmasi -	Salinan Sijil Pengekalan Tahunan -	Salinan Lesen Jenis A ALIRAN PERMOHONAN LESEN PENGILANG, PEMBORONG DAN LESEN MENGIMPORT

1.Permohonan Baru 2.Pembaharuan Lesen

Tindakan/Jawapan PERKARA – PERKARA YANG PERLU DIBERI PERHATIAN

1.	PEMBAHARUAN LESEN

	Permohonan pembaharuan lesen mestilah dikemukakan tidak lewat dari tiga (3) bulan sebelum tarikh luput lesen.

2.	TARIKH LUPUT LESEN

	Lesen Pengilang dan Lesen Mengimport mempunyai tarikh luput pada 31 Disember. 	Lesen Pemborong mempunyai tarikh luput pada 30 Jun.

3.	PERTUKARAN PREMIS

	Hanya premis (dan alamat) yang dinyatakan di dalam lesen saja yang diluluskan untuk aktiviti berkenaan. 	Sekiranya ada perancangan untuk pertukaran premis, sila maklumkan kepada Pusat Komplians dan Pelesenan, Biro Pengawalan Farmaseutikal Kebangsaan supaya pemeriksaan premis baru dapat diuruskan. 	Permohonan baru lesen berkenaan untuk premis baru perlu dibuat dan diluluskan oleh Pihak Berkuasa Kawalan Dadah sebelum perpindahan ke premis tersebut.

4.	TAMBAHAN KEPADA SENARAI KELUARAN LESEN PENGILANG DAN LESEN MENGIMPORT

	Hanya keluaran – keluaran berdaftar yang didapati di dalam Senarai Keluaran Lesen Pengilang atau Lesen Mengimport yang dibenarkan untuk dikilang atau diimport. 	Sebarang tambahan kepada senarai keluaran di atas perlu dipohon menggunakan borang untuk Senarai Tambahan (BPFK – 440) yang boleh diperolehi dari laman web BPFK (www.bpfk.gov.my)

KETERANGAN LESEN CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 PERATURAN 7 Prohibition against manufacture, sale, supply, importation, possession and administration.

PERATURAN 12 LICENCES 1.	The Director of Pharmaceutical Services may, subject to the pro-visions of these Regulations, issue any of the following licences subject to such conditions as he may impose :

(a)	a manufacturer’s licence in Form 2 in the schedule, authorizing the licensee to manufacture the registered products in the premises specified in the licence and to sell by whosale or supply the products; (b)	a wholesaler’s licence in Form 3 in the Schedule, authorizing the licence to sell by whosale or supply the registered products from the address of the business premises specified in the licence; (c) 	a clinical trial import licence in Form 4 in the Schedule, authorising the licensee to import any product for purposes of clinical trials, notwithstanding that the product is not a registered products; (d)	an import licence in Form 5 in the Schedule,authorising the licensee to import and sell by wholesale or supply the registered products from the address of the premises specified in the licence.

2.	Provided that drugs and cosmetics are not included together in one licence, any number of registered products may be included in any licence other than a clinical trial import licence, with shall include only one products.

3.	Subject to subregulation (2), the Director of Pharmaceutical Services may, on application by the licensee, add to the registered products included in any licence other than a clinical trial import licence, and make such addition or amendment to the conditions of the licence as are rendered necessary by the addition of the other registered products.

4.	Subject to regulation 17, a licence issued under these Regulations, other than a clinical trial import licence, shall be valid for one year.

5.	Subject to regulation 17, a clinical trial import licence shall be valid for such period, not exceeding three years from the date of issue of the licence, as may be specified in the licence. 6.	Every licence shall be personal to the licensee named in the licence and shall not be transferable to another person.

PERATURAN 13 APPLICATION FOR LICENCE

1.	An application for a licence under these Regulations shall be made in such manner or form as the Director of Pharmaceutical Services may require and shall be accompanied with a processing fee of  RM 1000.00 in the case of an application for a manufacturer’s licence and RM 500.00 in the case of an application for any other licence.

2.	The processing fee shall not be refundable.

3.	The applicant for a licence shall furnish such documents, particulars or information as the Director of Pharmaceutical Services mar require.

4.	Any person who knowingly supplies any false or misleading information to the Director of Pharmaceutical Services in connection with his application for a licence commits an offence.

PERATURAN 14 REFUSAL OF APPLICATION FOR LICENCE 1.	The Director of Pharmaceutical Services may, if he thinks fit and without assigning any reason, refuse any application for a licence.

PERATURAN 15 EXEMPTIONS AND SAVINGS

1.	Any person who wishes to import any product for the purpose of research in a school of pharmacy or a research or training institution or in order to obtain samples for purposes of registration may on application be exempted by the Director of Pharmaceutical Services from the provisions of regulation 7 ( 1 ).

2.	The requirement of regulation 7 ( 1 ) as regards a licence to supply or manufacture does not apply to the dispensing of any drug for the purpose of its being used for medical treatment of a particular patient or animal, by the following persons and in the following circumstances ;

(a)	a pharmacist or a person working under the immediate personal supervision of a pharmacist in a retail pharmacy; (b)	a person acting in the course of his duties who is employed in a hospital or dispensary maintained by the Federal or any State Government or out of

public funds or by a charity approved for the purposes of section 9 (1) (b) of the Poisons Ordinance 1952 or in an estate hospital and who is authorized in writing as provided in that section; and

(c)	a fully registered medical practitioner or a dental practitioner or a veterinary practitioner or a person working under the immediate personal supervision of such a practitioner if the drug in question is for the use of such practitioner or of his patients.

3.	Regulation 7 (1) (a) shall not apply to any drug manufactured by persons and in the circumstances described in subregulation (2) if the drug in manufactured for the purpose of dispensing.

4.	A school of pharmacy or any research or training institution which wishes to manufacture any product for teaching and research purposes may on application be exempted by the Director of Pharmaceutical Services from the provisions of regulation 7 (1).

5.	Any person who wishes to manufacture any product solely for the purpose of producing samples for clinical trials or for registration under these Regulations may on application be exempted by the Director of Pharmaceutical Services from the provisions of regulation 7 (1).

6.	Any person who wishes to import or manufacture any product solely for the purpose of treatment of any person suffering from a life – threatening illness many on application be exempted by the Director of Pharmaceutical Services from the provisions of regulation 7 (1) subject to such conditions or restrictions as he may impose in such exemption.

PERATURAN 16 CERTIFICATION

1.	The Director of Pharmaceutical Services may issue such certification on any matter relating to any product where such certification is required by any matter relating to any product where such certification is required by any country importing such a product.

2.	A fee of RM50.00 is payable on the issue of such certification.

PERATURAN 17 REVOCATION OF LICENCE

1.	The Director of Pharmaceutical Services may, at any time and without assigning any reason, revoke any licence issued under these Regulations and may amend the conditions to which such licence is subject.

2.	Subject to subregulation (3), any suspension or cancellation of the registration of any product under subregulation (1) shall similarly and at the same time affect any licence issued under these Regulations relating to that products.

3.	Notwithstanding subregulations (2), where a licence issued under these Regulations relates to several registered products the suspension or cancellation of the registration of any product under subregulation (1) shall not affect the position of other registered products listed in the licence.

PERATURAN 18 APPEAL

Any person aggrieved by any decision of the Authority or the Director of Pharmaceutical Services under these Regulations may make a written appeal to the Minister within fourteen days from the date the decision is made known to him and any decision of the Minister made on an appeal shall be final.